tag:blogger.com,1999:blog-5257782925655545192024-03-19T01:04:04.748-04:00Institutional Review BlogNews and commentary about Institutional Review Board oversight<br>of the humanities and social sciencesZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger637125tag:blogger.com,1999:blog-525778292565554519.post-22482506480738660972018-07-25T12:30:00.000-04:002018-07-25T12:30:41.771-04:00Seton Hall Law plans November conference on Revised Common Rule<p>On November 9, I will join other scholars to discuss the revised Common Rule at a one-day conference hosted by Seton Hall University: <a href="https://law.shu.edu/events/human-subject.cfm">Reimagining Human Subject Protection for the 21st Century: A Critical Assessment of the Revised Common Rule</a>. </p><br />
<p>The agenda is online at <a href="https://law.shu.edu/docsnoncommonspot/images/events/human-subject-agenda.pdf">https://law.shu.edu/docsnoncommonspot/images/events/human-subject-agenda.pdf</a></p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-22042831632031956902018-07-20T11:33:00.003-04:002018-07-20T11:33:50.287-04:00OHRP Draft Guidance on Oral History; No Mention of Examples<p>OHRP has posted draft guidance on “<a href="https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html">Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements</a>.”</p><br />
<p>The draft reiterates the distinctions made in the January 2017 Federal Register announcement of the new Common Rule, stating:</p><br />
<blockquote>It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups. <br />
</blockquote><br />
<p>Unlike the <a href="http://www.institutionalreviewblog.com/2018/07/ohrp-video-oral-history-of-specific.html">June 22 video</a>, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-18255447161499629682018-07-19T08:33:00.000-04:002018-07-19T08:33:48.416-04:00OHRP Video: Oral History of "Specific Leaders" Would Qualify as Research<p>On June 22, OHRP posted a video to YouTube, dated March 2018 and entitled “<a href="https://www.youtube.com/watch?v=Sptom2vU924&feature=youtu.be">When Does the Common Rule Apply?</a>,” featuring Misti Ault Anderson, Senior Advisor for Public Health Education at OHRP. The video includes a passage stating that while an oral history interview of “one individual” will no longer be considered research under the new Common Rule, a project about “specific leaders” would still be regulated.</p><br />
<p>I consider this statement to be at odds with the 18 January 2017 Federal Register announcement of the revised rule. However, Anderson tells me the video is an “education tool,” not official guidance, and that “we will be seeking public comment for consideration before developing the final guidance.”</p><a name='more'></a><br />
<p>The passage comes 3 minutes and 28 seconds into the video:</p><br />
<blockquote>The first category of activities that is deemed not to be research is scholarly and journalistic activities, and these include the collection and use of information that focuses directly on specific individuals about whom the information is collected. The key to understanding this set of activities is what was right in the middle of that description. It’s about only the specific individuals that are providing the information. So examples include: oral history, journalism, biography, literary criticism, legal research, and historical scholarship. So the activities being done are the things that make the difference. So let me give you some examples. Looking at historical scholarship: a historical study about the life of a specific civil rights leader, and only about that individual, would meet the requirements of this set of activities. It’s only about one individual, and cannot be generalized to a larger group. So that would not be research under the regulatory definition. However, a historical study about the societal impacts of the Civil Rights Movement and how it was driven by specific leaders in that movement, would qualify as research, under the regulatory definition.<br />
</blockquote><br />
<p>Compare the video’s example of “one individual” to the <a href="http://www.institutionalreviewblog.com/2017/01/united-states-of-america-frees-oral.html#more">Federal Register announcement</a>, describing the deregulation of oral history and related fields.</p><br />
<blockquote>The final rule also explicitly cites those fields and traditions as examples, in order to clarify that the focus is on the specific activities that collect and use information about specific individuals themselves, and not generalizing to other individuals, and that such activities occur in various fields of inquiry and methodological traditions.<br />
</blockquote><br />
<p>Thus, in January 2017, OHRP assured historians that we could study “specific individuals” (plural) without triggering IRB jurisdiction, but now it suggests that we can only study “one individual” at a time.</p><br />
<p>In response to my queries, Anderson writes, </p><br />
<blockquote>My wording in the example isn't sufficiently clear, and I think that is causing the confusion. <br />
The main point isn't that people would be interviewed. In the example, the point I was trying to make was this: (1) if information was collected about an individual or specific individuals in order to understand those individuals themselves, it would not be considered research, and (2) -and this is where I could be more clear-if information was gathered (people interviewed, etc.) to try to identify and understand characteristics, commonalities, or patterns of behaviors of people in general who participated in a movement or societal change (in this case), it might be considered to be research because it does not focus on the interviewed individuals themselves, but rather is designed to use information collected from those individuals to draw conclusions about other - in some ways similar - individuals.<br />
In short, as long as the activity is "focus[ing] directly on the specific individuals," it will not fall under the Common Rule.<br />
</blockquote><br />
<p>I leave readers to judge whether the video is consistent with that interpretation. </p><br />
<p>Anderson also writes,</p><br />
<blockquote>OHRP is working on a draft guidance document focusing on the scholarly and journalistic activities category of activities that are deemed not to be research. Once that document is ready, we will make it available and invite public comment on the guidance. At that point you, and others, will have the opportunity to provide feedback and comments on the draft guidance. <br />
</blockquote>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-92055166719123757712018-04-23T09:09:00.001-04:002018-04-23T09:09:22.505-04:00Feds Say New Common Rule Will Reduce Burdens and Offer Guidance—But Not Yet<p>In a new notice of proposed rulemaking, published in the Federal Register on April 20, HHS and other Common Rule Agencies identify three provisions of the new Common Rule as “burden-reducing.” Among them is the redefinition of research to exclude historical research. Yet the notice gives institutions either three or nine months to implement the reforms.</p><br />
<p>[“<a href="https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general">Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period</a>,” 83 Federal Register 17595 (April 20, 2018).</p><br />
<p>The “burden-reducing” label correctly implies that the corresponding provisions of the current Common Rule are unnecessarily burdensome. Yet rather than reducing the burdens immediately, the new NPRM gives institutions the choice of eliminating them in July 2018 or January 2019.</p><br />
<p>The notice presents this as a recognition of “entities’ possible inclinations to make all transitions at once.” To be sure, <a href="http://www.institutionalreviewblog.com/2015/12/i-agree-with-prim-on-something.html">federal agencies seem to favor massive, comprehensive, and infrequent change to incremental improvement</a>, but I wonder if research institutions feel the same. And it’s telling that the notice considers “entities” as the primary stakeholders in the decision. Recall that the <a href="http://www.institutionalreviewblog.com/2011/07/feds-ponder-biggest-irb-rules-changes.html">2011 ANPRM</a> aimed at “Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for <em>Investigators</em>.” (Emphasis added.) The new notice does not speculate how investigators might feel about the pace of transition.</p><br />
<p>The notice also states,</p><br />
<blockquote>We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution’s decision to elect to implement the three burden-reducing provisions or not.<br />
</blockquote><br />
<p>In <a href="http://www.institutionalreviewblog.com/2007/02/schwetz-promises-new-guidelines-new.html">February 2007</a>, OHRP promised such guidelines “by the end of the year.”</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-85198788548384828762018-01-19T08:58:00.001-05:002018-01-19T08:58:42.386-05:00Revised Common Rule Delayed at Least 6 Months<p>The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.</p><a name='more'></a><br />
<p>The official announcement is set to his the Federal Register on January 22, but an unpublished rule is online at <a href="https://federalregister.gov/d/2018-00997">https://federalregister.gov/d/2018–00997</a>. </p><br />
<p>Here’s the justification for delaying the new definitions of research and the new exemptions:</p><br />
<blockquote><p>The 2018 Requirements include four explicit categories of activities that have been deemed not research for the purposes of the Common Rule. In the absence of guidance, it would be difficult for institutions to fully take advantage of the exclusion of activities from the definition of research; therefore we now assume that many institutions would not have used these categories without guidance.</p><br />
<p>The 2018 Requirements also include five new exemption categories, and modify all but one exemption that exists in the pre–2018 Requirements. We have received feedback from SACHRP that many of the exemption categories will require significant guidance in order to be implemented. Areas where significant guidance is needed include: applying the categories of the new exemptions themselves, conducting limited IRB review (as required in four exemptions), developing and using broad consent (as required in two exemptions), utilizing the exemption for certain HIPAA covered activities, and understanding which federally supported or conducted nonresearch information collections qualify for exemption. Because the guidance necessary to implement these provisions has not yet been developed, we now assume that 50 percent of the regulated entities would not have taken advantage of the expansion in exemptions or the revised definition of research during the six-month delay.</p></blockquote><br />
<p>OHRP essentially argues that in the six and a half years from the 2011 ANRPM through today, it has been unable to craft regulatory language or accompanying guidance clear enough that institutions can use it to oversee research.</p><br />
<p>The truth is, since the crackdown of 1998, universities have spent twenty years guessing what OHRP wants from them. As Robert Klitzman writes in <em><a href="http://www.institutionalreviewblog.com/2015/09/schrag-reviews-klitzman-ethics-police.html">The Ethics Police</a></em>:</p><br />
<blockquote><p>The fact that federal agencies at times communicated in limited, incomplete, or frustrating ways appeared to compound these problems. Committees may request clarifications from OHRP and the FDA, but find the answers “unhelpful.” Interviewees said that sometimes the agencies simply didn’t respond; and at other times, did so unsatisfactorily, merely reiterating the regulations without offering clarification. ”If they don t want to say much,” Liza said, “they’ll just repeat the regulations in five different ways.” </p><br />
<p>In not issuing definitive official opinions, federal agencies leave committees to wrestle alone with these vagaries. Working in this interpretive vacuum without guidance can generate stress and discrepancies. “The Feds often seem to back away from taking a stand;’ Troy, the chair, reported. "They’ll turn it back to us, and say, ‘Its up to the IRB.’ They’ll come in and criticize us <em>later</em>.” Stephen concurred:</p><br />
<blockquote><p>Many times when you call for advice; they essentially just read back the regulations. You basically have to make your own decision, which is great, until you have an audit, and then you’re told you didn’t make the right decision. </p></blockquote></blockquote><br />
<p>Does anyone expect that another six months is going to fix this problem?</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-5464005914098292052017-05-31T11:29:00.003-04:002017-05-31T11:29:50.384-04:00Schrag on Whitney, Balanced Ethics Review<p><em>The Oral History Review</em> has posted my review of Simon Whitney’s 2016 book, <em>Balanced Ethics Review: A Guide for Institutional Review Board Members</em>. (I think that’s three distinct uses of “review,” right?)</p><br />
<p>[Zachary M. Schrag, “Balanced Ethics Review: A Guide for Institutional Review Board Members. By Simon N. Whitney,” <em>Oral History Review</em>, accessed May 30, 2017, <a href="http://dx.doi.org/10.1093/ohr/ohx030">doi:10.1093/ohr/ohx030</a>.]</p><br />
<p>I note,</p><br />
<blockquote><p>Whitney’s approach is basically utilitarian, arguing that the good research creates outweighs its harms. In this vein, he values social science research as the equivalent of medical research . . but what of research that, like much humanities research and a fair amount of social science, aims only to increase human knowledge? </p></blockquote><br />
<p>I conclude:</p><br />
<blockquote><p>As Whitney well understands, IRB members face considerable pressure to overregulate. The universities or medical schools in which they work may ask them to review research (including oral history) beyond the scope of regulations, or to protect institutions from lawsuits. They will learn that they themselves are far more likely to be sued for letting one controversial study (like SUPPORT) proceed than for needlessly impairing dozens of less risky projects. And if they do receive training from the dominant institutions, they are likely to hear that “efficiency itself is not a moral imperative or an ethical value” (25). Whitney pushes back against this pressure. His book is well crafted to promote its stated goal: balance.</p></blockquote><br />
<p>Oxford University Press asks that I not post a link to a free-access version of the review here, but it does allow me to post that link on <a href="https://zacharyschrag.com/irbs/">my personal website</a>. </p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-54790064567051613622017-04-21T11:36:00.000-04:002017-04-21T11:36:26.488-04:00Final Rule, three months later<p>It’s been three months since the announcement of the new Common Rule. Some reactions so far:</p><a name='more'></a><br />
<h2>Shweder and Nisbett hope for vast deregulation</h2><br />
<p>On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the <em>Chronicle of Higher Education</em> celebrating the new final rule:</p><br />
<blockquote><p>in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.</p></blockquote><br />
<p>In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”</p><br />
<p>[Richard A. Shweder and Richard E. Nisbett, “<a href="http://www.chronicle.com/article/Long-Sought-Research/239459.">Long-Sought Research Deregulation Is Upon Us. Don’t Squander the Moment</a>” <em>Chronicle of Higher Education</em>, March 12, 2017.</p><br />
<h2>Meyer asks, what’s new?</h2><br />
<p>On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has <a href="http://www.institutionalreviewblog.com/2009/10/ohrp-grudgingly-okays-self-exemption.html">grudgingly acknowledged</a> that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.</p><br />
<p>On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”</p><br />
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEieKVr548zOpEt1OsZ0iGnh4PyIuqUPnKWk-ekS8jphk8-MSvn_gyzFLpjVzbEw2FIqr5p_aE74pwfWZuMpboNKUbLvJUk4YVXR9v7JSgdjEKxxVNEzHtJVofXrnL8lLDgE3uUupqzTqCdM/s1600/C7DRbzxU8AEU-H6.jpg" imageanchor="1" ><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEieKVr548zOpEt1OsZ0iGnh4PyIuqUPnKWk-ekS8jphk8-MSvn_gyzFLpjVzbEw2FIqr5p_aE74pwfWZuMpboNKUbLvJUk4YVXR9v7JSgdjEKxxVNEzHtJVofXrnL8lLDgE3uUupqzTqCdM/s400/C7DRbzxU8AEU-H6.jpg" width="400" height="225" /></a><br />
<br />
<p>(GIF re-posted here with Meyer's permission.)</p><br />
<p>Comments posted to the Chronicle website made similar points. They noted, for instance, that the final rule abandons the ANPRM’s proposal that for minimal-risk projects, “researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study,” and that regulations could “discourage having each of these registration forms undergo a comprehensive administrative review prior to commencing the study or even afterward.”</p><br />
<h2>Shweder and Nisbett remain hopeful</h2><br />
<p>In an April 19 essay, marking three months since the Federal Register publication of the proposed final rule, Shweder and Nisbett acknowledge the criticism. But they also emphasize that the proposed rule eliminates “the box” that encouraged institutions to submit all research, not just projects funded by the federal government, to federal oversight. “The Office for Human Research Protections has made it clear that it has no interest in overseeing research not funded by agencies bound by the Common Rule, the federal government regulations for human-subject research, or in applying the new regulations to such projects,” they write, and they encourage universities to take advantage of the new climate.</p><br />
<p>[Richard A. Shweder and Richard E. Nisbett, “<a href="http://www.chronicle.com/article/Don-t-Let-Your/239823">Don’t Let Your Misunderstanding of the Rules Hinder Your Research</a>,” <em>Chronicle of Higher Education</em>, April 19, 2017]</p><br />
<h2>Dingwall Despairs</h2><br />
<p>Writing in <em>Nature Human Behavior</em>, Robert Dingwall despairs that the final rule did not adopt the bolder approaches of the National Research Council’s 2014 report, <a href="http://www.institutionalreviewblog.com/2014/01/national-research-council-issues-irb.html">Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences</a>. He writes, “The results are incoherent and unlikely to reduce the mistrust between social scientists and ethics regulators.”</p><br />
<p>[Robert Dingwall, “Social Sciences Lose out Again in Common Rule Reform,” <em>Nature Human Behaviour</em> 1 (April 7, 2017): 83, <a href="http://dx.doi.org/10.1038/s41562-017-0083">doi:10.1038/s41562–017–0083</a>.]</p><br />
<h2>Anthropologists, sociologists mostly silent</h2><br />
<p>The American Sociological Association announced the biggest change to human subjects regulation in a generation in a 240-word item on <a href="http://www.asanet.org/sites/default/files/attach/footnotes/q1-17_footnotes.pdf">page 3 of its newsletter</a>. No analysis of how this will affect sociological research, or the <a href="http://www.institutionalreviewblog.com/2017/01/why-is-felice-levine-satisfied.html">failure of the final rule to incorporate the ASA’s recommendations</a>. I haven’t found even that much notice by the <a href="http://www.americananthro.org/">American Anthropological Association</a>. Also nothing that I can find from the <a href="http://www.lawandsociety.org/">Law and Society Association</a>, which in <a href="http://www.institutionalreviewblog.com/2008/11/irbs-vs-law-and-society.html">2007 and 2008</a> was so vocal on IRB issues. </p><br />
<h2>Historians are happy</h2><br />
<p><a href="http://blog.historians.org/2017/01/oral-history-excluded-irb-oversight/">Historians are just happy to be free</a>. </p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-19247584665845169682017-02-17T10:10:00.001-05:002017-02-17T10:10:38.321-05:00Institutional Review Blog past and future<p>This winter, the Institutional Review Blog passed two milestones. In December it turned 10 years old, and in January it reported on the largest reform in U.S. human subjects regulations since 1981. This seemed like a good time to archive another batch of postings, so I have deposited a second PDF with the the Mason Archival Repository Service. Now all postings from the start of the blog through the end of January 2017 can be found at <a href="http://hdl.handle.net/1920/8642">http://hdl.handle.net/1920/8642</a>. Many thanks to Wally Grotophorst, Associate University Librarian, George Mason University, for making this possible.</p><br />
<p>I am less sure about the future of this blog. In ten years I have posted about 445,000 words, a considerable investment of time and effort. I see no reason to formally close the blog, but I may be posting a good deal less frequently as I focus on completing my book about the Philadelphia riots of 1844. </p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-43736588594117252072017-01-19T18:02:00.000-05:002017-01-19T18:02:11.977-05:00You know, it's very strange<p>On 19 January 2007, <a href="https://www.insidehighered.com/news/2007/01/19/irb"><em>Inside Higher Ed</em> reported</a> the launch of this blog. Here is the kicker from that story:</p><br />
<blockquote><p>Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”</p></blockquote><br />
<p>Ten years later, <em>to the day</em>, the amended regulations are in the Federal Register. </p><br />
<p><a href="https://books.google.com/books?id=cSQT4aQ7r10C&lpg=PA382&dq=%22revenge%20business%20so%20long%22&pg=PA382#v=onepage&q=%22revenge%20business%20so%20long%22&f=false">You know, it’s very strange—I have been in the revenge business so long. Now that it’s over, I don’t know what to do with the rest of my life.</a></p><br />
<p>Should I consider piracy?</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-72380484519468164032017-01-19T10:56:00.000-05:002017-01-19T11:13:08.525-05:00Why is Felice Levine satisfied?<p><em>Inside Higher Ed</em> reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.</p><br />
<p>[Scott Jaschik, “<a href="https://www.insidehighered.com/news/2017/01/19/us-issues-final-version-common-rule-research-involving-humans.">U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans</a>,” <em>Inside Higher Ed</em>, January 19, 2017.]<br />
<br />
[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]<br />
<a name='more'></a></p><br />
<p>Here’s Scott Jaschik’s reporting on social science reactions to the final rule:</p><br />
<blockquote><p>Early reactions from social science groups to the changes in the common rule were positive. Various provisions suggest that institutional review boards, which must review proposals to study humans, work to understand the needs of different kinds of researchers, and that there are different levels of risk associated with taking an experimental drug and answering confidential survey questions.</p><br />
<p>A statement from Felice J. Levine, executive director of the American Educational Research Association, said, “The revised regulations definitely show the care and hard work that went into this extensive effort to modernize the common rule. An open process that began in July 2011 has led in January 2017 to regulations that are more nuanced and that far better align human research protection and social and behavioral science research, taking into consideration level of risk and benefits. It is a fine outcome for research participants and for human science.”</p><br />
<p>For anthropology, the reaction was more mixed. Anthropologists pushed hard for specific mention of “participant observation” (a key tool of their discipline). The hope is that mention of this methodology will make it easier for institutional review boards to approve projects involving this approach. Sometimes in the past, [Edward Liebow of the American Anthropological Association] said, IRB members or others have not understood that the relationship between an anthropologist engaged in participant observation isn’t the same as a scholar who is interviewing his or her research subjects.</p><br />
<p>But he said that his association was “especially concerned” that the final version of the rule did not exempt participant observation, as his organization had urged.</p></blockquote><br />
<p>I can understand Liebow’s disappointment; the final rule offers little aid to frustrated ethnographers. </p><br />
<p>I have more trouble understanding Levine’s satisfaction. In response to the 2011 ANPRM, she drafted the “<a href="http://www.institutionalreviewblog.com/2012/01/sbs-white-paper-calls-for-drastic.html">Social and Behavioral Science White Paper</a>,” which called for dramatic reforms to the IRB process. The final rule is largely unresponsive to the concerns expressed in that paper:</p><br />
<ul><li>The White Paper objected to the current §46.116(a)(2) requirement that informed consent include a “description of any reasonably foreseeable risks or discomforts to the subject,” suggesting that “reasonably foreseeable harms” might better apply. The final rule does not make that change.</li>
<li>The White Paper objected to the current rule’s “general mandate to apprise subjects as part of the informed consent process of alternatives to treatment or why it may be in their best interest not to participate. (Such requirements are sometimes appropriate, but add complexity and foster confusion where they are not.)” The final rule maintains the current rule’s language on this point.</li>
<li>The White Paper “strongly support[ed] the requirement of an appeals process.” This was not included in the NPRM or final rule.</li>
<li>The White Paper argued that “it should be incumbent on the reviewer to state specifically in writing what aspect of a registration document leads to doubt a project’s excused status and to refrain from review where it finds none.” The final rule [§__.115(a)(3)] takes a small step in requiring documentation of “the rationale for conducting continuing review of research that otherwise would not require continuing review,” but it does not require such a rationale for denying an exemption.</li>
</ul><br />
<p>The final rule, with its announcement, is 543 pages long in its initial format, so perhaps it includes some of the White Paper’s recommendations that I have overlooked. </p><br />
<p>It’s also possible that Levine is thinking primarily of the final rule’s provisions for research “involving normal educational practices,” which I have not examined so closely. But the new rule seems to make this research harder; to win exemption, research must be “not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction,” something not required by the current regulations.</p><br />
<p>So far, I can’t see why Levine is calling this a win.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-3273692000076689802017-01-19T09:08:00.000-05:002017-01-19T09:08:43.988-05:00A social scientist’s guide to the Final Rule<p>On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a <a href="http://www.institutionalreviewblog.com/2017/01/united-states-of-america-frees-oral.html">huge victory for historians</a>, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.</p><br />
<p>In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.<br />
<a name='more'></a><br />
<h2>No biospecimens overhaul; less controversy</h2></p><br />
<p>The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the <a href="http://www.institutionalreviewblog.com/2016/07/the-ethical-imperialism-of-nas.html">National Academies of Sciences, Engineering, and Medicine</a> and <a href="https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2016-january-5-recommendation-nprm-attachment-a/index.html">SACHRP</a>. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole. </p><br />
<p>The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The <a href="https://meadows.house.gov/first-100-days">House Freedom Caucus</a> opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more. Of the $13.3 billion estimated costs, $12.2 billion came from complying with the new rules on secondary use of biospecimens (80 FR 54021). The new estimate is that changes will have benefits of $1.9 billion over 10 years and costs of only $528 million (at a 3 percent discount rate, which is where the $13.3 billion figure came from). If Republicans can consider benefits as well as costs (as the House Freedom Caucus has so far failed to do), perhaps the jettisoning of those rules will reduce hostility to the overall reform.</p><br />
<h2>Agencies continue to ignore statutory limits</h2><br />
<p>Like previous versions of 45 CFR 46, this final rule claims as its statutory authority 42 U.S.C. 289, which applies to “biomedical and behavioral research,” yet it fails to restrict its provisions to such activities. The announcement explains:</p><br />
<blockquote><p>Regarding the concerns expressed that the Common Rule departments and agencies are not authorized to regulate humanities and social science research, this challenge had been asserted previously against the 1981 HHS protection of human subjects regulations, as well as the 1991 Common Rule, and in each case the regulatory agencies concluded that the regulation of humanities and social science research is justified. We continue to assert the authority to regulate humanities and social science research that falls within the scope of the final rule.</p></blockquote><br />
<p>Note the verb “assert.” Not find, show, explain, reason. No statutory analysis. Just raw assertion of power.</p><br />
<p>The announcement cites the 1981 and 1991 Federal Register announcements, neither of which states that “the regulatory agencies concluded that the regulation of humanities and social science research is justified.” I know of no such formal finding.</p><br />
<p>Similarly, the final rule abandons the NPRM’s proposal to impose review on clinical trials “regardless of the funding source of the specific clinical trial” without reference to the statute. Rather than concede that HHS lacks the statutory authority for such a requirement—something it did concede in 1981 (46 FR 8369)—it claims, “our proposal for extending the Common Rule to currently unregulated clinical trials would benefit from further deliberation.”</p><br />
<h2>Oral history is clear; ethnography is still regulated</h2><br />
<p>As I noted in my <a href="http://www.institutionalreviewblog.com/2017/01/united-states-of-america-frees-oral.html">previous post</a>, the new definition of research includes a provision [ §__.102(l)(1)] explicitly excluding “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.” This is a big deal not only for historians and journalists, but also for literary critics, law professors, and political scientists who do on-the-record interviews. </p><br />
<p>The final rule eliminated the special exemption for research with public officials on the grounds that it is no longer needed. Now, if you are running a low-risk survey of public officials, you seek clearance under the exemption for low-risk surveys, while if you want to “hold specific elected or appointed officials up for public scrutiny,” you aren’t doing research under the revised definition of research. This strikes me as an improvement, since it provides the same clearance for research about corporate executives, rock stars, lobbyists, and other public figures as it does for the more narrow category of officials and candidates. </p><br />
<p>Unfortunately, the new rule continues to cover ethnography:</p><br />
<blockquote><p>Activities described in §__.102(l)(1) may sometimes be performed in the fields of anthropology or sociology, but not all activities characteristic of these fields are outside of the rule. Studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand their beliefs, customs, and practices, and the findings apply to the studied community or group, and not just the individuals from whom the information was obtained, fall within the scope of the definition of research of the final rule.</p></blockquote><br />
<p>How exactly ethnographers are supposed to do their work is another question. At the <a href="http://www.institutionalreviewblog.com/2015/11/does-nprm-exclude-or-exempt-ethnography.html">20 October 2015 Town Hall</a>, OHRP officials could not figure out how the NPRM would govern ethnography. And I’m not sure the final rule is any clearer. </p><br />
<h2>Changes to ethnography and surveys</h2><br />
<p>The final rule does make some changes that may affect ethnography and surveys, perhaps to the good.</p><br />
<ul><li>Easier to talk with prisoners, pregnant women, and the disabled</li>
</ul><br />
<p>For ethnography and other social science work that still falls under the definition of research, but that is exempt, it will be possible to maintain that exemption if the population studies “only incidentally includes prisoners.” And “pregnant women or ‘handicapped’ or physically disabled individuals” are now considered able to think for themselves, so no special review of research involving them is required. </p><br />
<ul><li>Modified exemption for interviews and surveys</li>
</ul><br />
<blockquote><p>(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:<br />
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;<br />
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).</p></blockquote><br />
<p>The addition of “by the investigator” in part (i) is helpful. If a participants wants to take notes, that doesn’t affect the researcher’s exemption. The addition of part (iii) allows another path to exemption not present before. At some point in the future, HHS will issue guidance explaining what privacy procedures qualify a study for this exemption.</p><br />
<ul><li>No more checking the box</li>
</ul><br />
<p>HHS “plan[s] to implement the proposed nonregulatory change to the assurance mechanism to eliminate the voluntary extension of the FWA to nonfederally funded research.” The final rule explains:</p><br />
<blockquote><p>We expect this change to have the beneficial effect of encouraging some institutions to explore a variety of flexible approaches to overseeing low-risk research that is not funded by a Common Rule department or agency, without reducing protection of human subjects, thus furthering the goal to decrease inappropriate administrative burdens.</p></blockquote><br />
<p>Conceivably this could help ethnographers win exemption.</p><br />
<ul><li>Modified consent rules</li>
</ul><br />
<p>I confess that I haven’t been able to digest the complex new rules about obtaining consent. I do note that the final rule allows IRBs to waive the requirement for a signed informed consent form if</p><br />
<blockquote><p>the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.</p></blockquote><br />
<p>The regulations have, since 1981, allowed waivers of consent forms for “procedures for which written consent is normally required outside of the research context,” like talking with people. (Whether IRBs have heeded this provision is another matter.) So I’m not sure that the addition of distinct groups here will change anything for ethnographers. </p><br />
<h2>Delayed changes to “minimal risk,” exemption determination, and privacy protections</h2><br />
<p>The final rule abandons some NPRM proposals in favor of buying time by reducing them to matters of guidance. These include:</p><br />
<ul><li><p>Changing the definition of minimal risk. HHS may still develop a list of examples of minimal-risk activities, but it will do so outside of the regulatory track.</p></li>
<li><p>Creating an “exemption determination tool,” which researchers could use to determine if their proposals were exempt from review. Like the list of minimal-risk activities, this is something that HHS can continue to work on without a regulatory change. </p></li>
<li><p>Privacy protections. “Rather than promulgate a regulation that lacked sufficient specificity, we determined it would be preferable to maintain the requirement that IRBs review research studies to ensure that appropriate privacy and security safeguards are in place to protect research subjects, but include a commitment that the Secretary of HHS will issue guidance to assist IRBs in appropriately protecting subjects’ privacy and confidentiality. This guidance would take into consideration, among other things, the level of identifiability and sensitivity of the information being collected.”</p></li>
</ul><br />
<h2>Limited restraints on IRBs</h2><br />
<p>The final rule states that “An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §__.104 for which limited IRB review is a condition of exemption.” It does not explicitly forbid IRB review of exempt research. And since the big problem with exempt research has been jumping through hoops erected by IRB staff, it’s not clear how much of a difference this will make either way.</p><br />
<p>IRBs now must document their reasons for escalating review:</p><br />
<blockquote><p>The final rule includes the NPRM proposal that IRBs document decisions to require continuing review or full board review even in circumstances when such review is not required because we believe it is important to document why an IRB is making a determination that differs from the regulatory baseline. This also helps to promote the principle of justice (as applied to IRB operations). Note that nothing in these regulations prevents an institution from authorizing an IRB to apply standards that exceed those in the regulations, if indeed the institution has chosen to do so.</p></blockquote><br />
<p>Beyond that, there’s scant due process protections in the final rule. No guaranteed appeals, for instance. No requirement that IRBs base their decisions on evidence.</p><br />
<p>In sum, the final rule is great news for researchers whose work will no longer be subject to IRB oversight. I’m less sure it will significantly help those still subject to regulation.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-32781791171551642382017-01-18T13:51:00.000-05:002017-01-18T13:51:26.742-05:00United States of America Frees Oral History!<div class="separator" style="clear: both; text-align: center;"><a href="http://digital.tcl.sc.edu/cdm/ref/collection/jbgrtwrsm/id/4287" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOsvr90sJ2Y3YErrNKHd8eqoejt4KlWDBzTQ8qDtJk-HnHQsOkxeJvs9JI66ByyTL6XI-bEXRvCgw3_INxjtz2omgNJ5OvdE7_YxhJIPuD2TuV1cuBOWwbVVlxVBk9bQnDyU-FnrSNDU1-/s320/victory%252Bcrop.png" alt="detail of sheet music for 'Victory' by M. K. Jerome, Jack Wilson, Ben Bard, 1918" width="320" height="144" /></a></div><br />
<p>This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.</p><a name='more'></a><br />
<p>The NPRM somewhat confusingly listed a number of activities “deemed not to be research” in §__.101, then presented the definition of research itself in §__.102. The final policy more logically defines research, then lists “activities … deemed not to be research.” </p><br />
<p>Whereas the NPRM excluded “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected,” the final rule offers a broader exclusion:</p><br />
<blockquote><p><strong>For purposes of this part, the following activities are deemed not to be research:<br />
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.</strong> [§__.102(l)(1)]</p></blockquote><br />
<p>(Emphasis added, because I can.)</p><br />
<p>So freedom depends on the activity, not the discipline, with literary critics, law professors, and others who interview individuals benefiting. Another section of the announcement notes that this provision will also apply to political scientists and others who hope “to hold specific elected or appointed officials up for public scrutiny, and not keep the information confidential.” </p><br />
<p>The announcement explains the reasoning:</p><br />
<blockquote><p>In these activities, the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not necessarily to protect them from public scrutiny. For example, a biographer might collect and present factual information to support the biographer’s opinion about the character of an individual to show that the individual does not deserve the positive reputation he or she enjoys in society. These fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories. We note that this consent standard should address the issue of oral histories of tribal members. For these reasons, we have determined that it is appropriate to remove these activities from the definition of research and from the scope of the Common Rule.</p><br />
<p>In response to public comments, §__.102(l)(1) refers to more fields and methodological traditions than were proposed in the NPRM. The final rule also explicitly cites those fields and traditions as examples, in order to clarify that the focus is on the specific activities that collect and use information about specific individuals themselves, and not generalizing to other individuals, and that such activities occur in various fields of inquiry and methodological traditions. Literary criticism has been added as an example because while a piece of literary criticism might focus on information about the author(s), it would typically focus on the specific author(s) in view. Legal research has been added as an example because it would often focus on the circumstances of specific plaintiffs or parties involved in a case. It is not the particular field that removes the activity from the definition, but rather the particular activity’s focus on specific individuals.</p></blockquote><br />
<p>I will be posting more later about the potential effects of the revised rule on the humanities and social sciences more generally. For now, I salute all those who worked for so many years to liberate oral history, especially Jonathan Knight, Cliff Kuhn, Don Ritchie, Roy Rosenzweig, Linda Shopes, Rob Townsend, and everyone who took the time to comment on the ANPRM and NPRM. </p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com1tag:blogger.com,1999:blog-525778292565554519.post-59239570864463821042017-01-07T22:25:00.000-05:002017-01-07T22:25:08.434-05:00Common Rule reform still in suspense<p>A proposed final rule on human subjects protections made it to the Office of Management and Budget on Wednesday, January 4. </p><br />
<p>Jeannie Baumann of Bloomberg thinks this means that we’ll see it in the Federal Register before January 20. But she also quotes Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, predicting that Congress will overturn the reform, since it appears on the <a href="https://meadows.house.gov/first-100-days">House Freedom Caucus hit list</a>. </p><br />
<p>Wake me up when it’s over. </p><br />
<p>[Jeannie Baumann, “<a href="https://www.bna.com/white-house-takes-n73014449436/">White House Takes Final Steps to Revamp Medical Research Rule</a>,” <em>Bloomberg BNA</em>, January 6, 2017.]</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-73334184256929644842017-01-02T12:08:00.000-05:002017-01-02T12:08:07.766-05:00Reforms for “21st century science” would have been good for the 20th too<p>A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.</p><br />
<p>[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” <em>Journal of Medical Internet Research</em> 18, no. 12 (2016): e329, <a href="http://dx.doi.org/10.2196/jmir.6634">doi:10.2196/jmir.6634</a>.]<br />
<a name='more'></a> </p><br />
<h2 id="fiverecommendations">Five recommendations</h2><br />
<p>The team presents its proposals under five headings, but I see the second and fifth as similar in intent.</p><br />
<ul><li>Redesigning the Consent Form and Process</li>
</ul><br />
<p>There’s broad consensus that <a href="http://www.institutionalreviewblog.com/search?q=consent+form">written consent forms often fail</a> to give prospective research participants the information they need to make a good decision. The UCSD team proposes consent forms based on Creative Commons licenses (like the one used by this blog). “Research studies,” they explain, “could create three consent forms: one that contains all the legalese and scientific exposition; one in plain English that presents the facts; and a third that is simplified even further and presents risks in bullet point format.”</p><br />
<ul><li>Empowering Researchers to Protect Participants</li>
</ul><br />
<p>Though the authors call for “empowering researchers,” really they are calling for expert peer review:</p><br />
<blockquote><p>Researchers intending to engage in human-participant research could produce a document that lays out plans and risks of the research. They could then offer those documents, along with an outline of the proposed consent process, for review by their peers. Peers would be researchers in the field of relevance for the research. These documents could be posted on the Web in the same way clinical trials are registered; not to get approval but to create a public record of the research … </p><br />
<p>Using [a] Web-based resource, within a few hours, researchers posing questions such as “How do I ensure that I won’t cause harm by asking this interview or survey question?” would receive answers from researchers who have been rated in terms of experience and expertise in human research protections. Elements of the plans could ultimately become like “protection modules” that could be swapped in and out of consent forms and research protocols, drawing attention to highly ranked modules.</p></blockquote><br />
<ul><li>Reinforcement and Learning From Experience</li>
</ul><br />
<p>Like <a href="http://www.irbnetresources.org/news/081109_IIS.pdf">Greg Koski</a>, the San Diego team sees the aviation safety system as a promising model. To encourage the sharing of important information, that system relies on more transparency, and less punishment for non-compliance.</p><br />
<blockquote><p>Pilots who have a “bad” landing or make another safety-related error who self-report their mistake are spared from punishment, but those who do not report it themselves are penalized if someone elects to report. Analogously, as an alternative to an IRB, in this system, researchers who create a protocol they believe to be safe, who then observe a harm during the research and who report that harm to their university or institution, present an opportunity for the research institution and community to learn how to prevent future harm.</li></p></blockquote><br />
<ul><li>Increasing Efficiency of the Institutional Review Board</li>
</ul><br />
<p>The authors call for several measures to track and ultimately reduce the costs of IRB review. Of particular concern to this blog is their suggestion that IRBs “use the ‘exempt’ category to a greater degree, as it was intended. The exempt category is frequently appropriate for the vast majority of social and behavioral science studies, yet it is underused, which leads to delays in review and approval and, thus, wasted resources.”</p><br />
<ul><li>Review of Research That Leverages Technological Advances</li>
</ul><br />
<p>The authors claim that new technologies, such as “mobile, visual imaging, pervasive sensing, and geolocation tracking technologies present new ethical and regulatory challenges,” and suggest that “virtual network composed of researchers, technologists, and bioinformatics experts may prove to be a workable solution to augment or replace the traditional IRB review process resulting in an informed and meaningful human protections review of 21st century science.” This sounds a lot like their second recommendation.</p><br />
<h2 id="thesearen’tnewproblems">These aren’t new problems</h2><br />
<p>Like <a href="http://www.institutionalreviewblog.com/2016/12/big-data-researchers-call-for-irb.html">Metcalf and Crawford</a>, the San Diego authors implausibly suggest that today’s IRB structure once made sense, but has been overtaken by events.</p><br />
<blockquote><p>While IRBs have helped address this critical need, the IRB system has not kept pace with the evolution of research methods and practices or current and emerging trends in science and technology. The fact that the system has become antiquated calls into question whether the IRB continues to foster the protection of human research participants per the principles originally put forth in the Belmont Report. New forms of research enabled by technological advances in information technology and data science appear to be particularly challenging to IRBs, yet clear standards to guide best practices are not well established.</p></blockquote><br />
<p>In fact, most of the problems they raise are not unique to “21st century science.” IRBs have wasted resources meddling with social science wasteful and inappropriate regulation of social science research since the 1960s. In the 1970s, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research discussed participants’ struggle to understand consent forms and the need to get expert judgment to understand the risks of specific methods. The exemptions which the authors want to see applied date to 1981. Punishing researchers, rather than encouraging them to learn from mistakes, has been a bad idea from the start.</p><br />
<p>The authors are thus wrong to suggest that these problems arose with cellphones and social media. It is not that the IRB system has become antiquated; rather, it never scaled up well from its small start in the 1960s. The reforms suggested here would have been as useful half a century ago.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-76836928366344584782016-12-15T10:36:00.002-05:002016-12-15T10:36:09.348-05:00Calls for Ethical Pluralism<p>In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice. </p><br />
<p>[Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” <em>Sociological Research Online</em> 21, no. 4 (2016): 7, <a href="http://dx.doi.org/10.5153/sro.4127">DOI: 10.5153/sro.4127</a>; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), <a href="http://dx.doi.org/10.2139/ssrn.2861908">DOI: 10.2139/ssrn.2861908</a>.]<br />
<a name='more'></a><br />
<h2>Emmerich seeks professional ethics</h2></p><br />
<p>Emmerich argues that </p><br />
<blockquote><p>the social sciences can lay claim to a democratic ideal as its ‘higher good’ and, therefore, its guiding ethos or end… . </p><br />
<p>Given this end – democracy – social science research is persuaded not for its own sake or for the sake of knowledge in itself. Rather, its pursuit is rooted in the (admittedly diverse) socio-political needs of ‘democracy,’ understood as an ethos or normative as an end in itself. </p></blockquote><br />
<p>Because of the importance of this work, he argues, researchers should not be constrained by ethics committees. Instead, he proposes that social scientists be judged by the equivalent of clinical ethics committees (CECs), which Emmerich describes as </p><br />
<blockquote><p>forums healthcare professionals can attend in order to discuss any ethical issues they encounter. Committee members are usually healthcare professionals but may also include lawyers, theologians, (bio)ethicists, and patient representatives or lay persons. Debates are relatively informal and if a committee offers a collective opinion – which is not always the case – decisions regarding any action remain the responsibility of those professionals directly involved in the case. CECs therefore provide a forum for debate and, as such, a means to improve the quality of ethical reflection in practice.</p></blockquote><br />
<p>Were social scientists trusted to the same degree as these healthcare professionals, they could</p><br />
<blockquote><p>justify the ethical aspects of their proposal with reference to the specific disciplinary norms that guide their work as professionals. The subsequent discussion would, of course, offer critique or raise additional issues as necessary. Such committees could, if they saw fit or if it were considered helpful to do so, produce a written comments or recommendations but, in so far as they are justified in doing so, the individual researcher could proceed within the boundaries of their own professional ethics.</p></blockquote><br />
<p>I’ve long thought that <a href="http://www.institutionalreviewblog.com/2007/01/why-not-make-irb-review-voluntary.html">making ethics review voluntary</a> could force ethics committees to improve the quality of their recommendations. As it stands, committees can use threats to impose their will, so they need not persuade researchers of the value of their suggestions. If stripped of this power, they would need to make suggestions good and clear enough to inspire voluntary compliance. But I’m less sure that such a switch requires or merits the wholesale reframing from research ethics to professional ethics. If your profession is research, aren’t research ethics a form of professional ethics?</p><br />
<p>I also wonder about Emmerich’s comparison of social science to “the true professions of law, medicine, [and] the clergy.” It strikes me that a key characteristic of these professions is the ability (<a href="http://www.vox.com/2014/6/24/5838690/why-is-dr-oz-still-a-doctor">in theory</a>) of fellow professionals to disbar, debar, or defrock. Social scientists do not have such power. In my essay, “Ethical Pluralism,” in <em><a href="http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html">The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review</a></em>, Will C. van den Hoonaard and Ann Hamilton, eds., (University of Toronto Press, 2016), I concluded that greater trust in the scholarly professions would likely require less reliance on threats. Does Emmerich agree?</p><br />
<h2>Gontcharov attacks TCPS2</h2><br />
<p>Gontcharov’s main argument is that Canada’s Tri-Council Policy Statement inappropriately imposes a “positivist understanding of research as a universal standard for all research disciplines.” As a result, he argues</p><br />
<blockquote><p>it is unavoidable that some research initiatives based on alternative or mixed methods started to experience challenges in passing ethics review. Since the format of ethics review is tailored to positivist research, “qualitative” researchers try to fit in the required framework – even if it is hardly relevant – when/thus filling out REB forms, identifying risks of harm, answering questions about anonymity and generalizability of data, or designing written consent forms. If they anticipate significant challenges in passing ethics review, they will probably decide against pursuing the project. (26)</p></blockquote><br />
<p>Unlike the United States, Canada has given social scientists formal roles in shaping human subjects guidelines. But Gontcharov suggests that quantitative social scientists sold out their less positivist fellows:</p><br />
<blockquote><p>The reason why many SSH (social science and humanities) researchers would not object the biomedical framework as a whole, searching for solutions to existing problems from within, is reflective of the overall methodological structure of the social sciences. This structure features a positivist core and antipositivist periphery. From this perspective – the expansion of the positivist framework can be seen as an attempt to colonize the periphery by the social sciences’ methodological core. Accordingly, methodological colonialism is an inner business of the social sciences, rather than an effort of the biomedical sciences to bring them into their orbit. (15)</p></blockquote><br />
<p>Gontcharov claims that while the 2010 and 2014 revisions to the TCPS introduced some “undoubtedly progressive” elements, “the biomedical conceptual framework remains largely intact, [so] all initiatives at knowledge production that do not fit the required protocol format continue to be censored or modified by researchers themselves in order to resemble the standard.” </p><br />
<p>I am puzzled by this claim, since the 2010 revision addressed many of the problems that Gontcharov identifies. For instance, Gontcharov claims that under TCPS “it is assumed that researchers will follow the approved design until research is completed.” But since 2010, TCPS2 has specifically noted that </p><br />
<blockquote><p>Although initial research questions may be outlined in the formalized research proposal, REBs should be aware that it is quite common for specific questions (as well as shifts in data sources or discovery of data sources) to emerge only during the research project. Due to the inductive nature of qualitative research and the emergent design approach of the research, some of these elements may evolve as the project progresses. (Article 10.5). </p></blockquote><br />
<p>Researchers are free to tinker with their research design without additional review unless “changes of data collection procedures would represent a change in the level of the risk that may affect the welfare of the participants.” </p><br />
<p>Similarly, Gontcharov complains that</p><br />
<blockquote><p>Written consent forms are a feature of REB oversight, which has a demoralizing effect on researchers, since they realize that they can only pass ethics by accommodating the elements that are native to research ethics boards, but potentially foreign to their projects. </p></blockquote><br />
<p>Again, TCPS2 addressed this problem in 2010:</p><br />
<blockquote><p>In some types of research, and for some groups or individuals, written signed consent may be perceived as an attempt to legalize or formalize the consent process and therefore may be interpreted by the participant as a lack of trust on the part of the researcher. In these cases, oral consent, a verbal agreement or a handshake may be required, rather than signing a consent form. In some cultures, the giving and receiving of gifts symbolizes the establishment of a relationship comparable to consent. (Article 3.12)</p></blockquote><br />
<p>As a final example, Gontcharov laments that </p><br />
<blockquote><p>REB professionals rely on a hierarchically-structured concept of power, <em>power as dominance</em>, assuming that researchers have <em>power over</em> their human participants. On the other hand, participatory researchers do not operate from within this “power over” perspective, since the context presupposes a more nuanced, multidimensional understanding of power, in which even the very distinction between researches and participants may be blurred or even irrelevant.</p></blockquote><br />
<p>TCPS2 agrees:</p><br />
<blockquote><p>In some cases, participants hold equal or greater power in the researcher-participant relationship, such as in community-based and/or organizational research when a collaborative process is used to define and design the research project and questions, or where participants are public figures or hold other positions of power (e.g., research involving economic, social, political or cultural elites). (Chapter 10, General Approach and Methodological Requirements and Practices.) </p></blockquote><br />
<p>To be sure, <a href="http://www.institutionalreviewblog.com/2016/08/will-tcps2-improvements-reach.html">as Nancy Janovicek has written</a>, not all REBs are following the guidance in the revised TCPS. But I am baffled by Gontcharov’s attack on a document that already includes key distinctions between biomedical and qualitative research that he wishes to highlight.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com1tag:blogger.com,1999:blog-525778292565554519.post-53835117163367128072016-12-12T16:08:00.000-05:002016-12-12T16:08:10.918-05:00Ten Years of Blogging<p>The Institutional Review Blog <a href="http://www.institutionalreviewblog.com/2006/12/introduction.html">launched ten years ago today</a>. I would like to think that with or without a new Common Rule, it’s done some good, but I would dearly love to see oral history liberated in the next 39 days.</p><br />
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinNjg7u6D9xeJvrIX5PCJ8WLbl1sfgHAQU2UI16VrP18A9LqA64izjwoaDGQCW8IhfbJhliNf_OjDK5t4V-GYIVGNkRo4JWpCD16axNp7c8LyLV8G_iEs0fIATsJZB_gUyB6gv8whrpxOr/s1600/regz.gif" imageanchor="1" ><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEinNjg7u6D9xeJvrIX5PCJ8WLbl1sfgHAQU2UI16VrP18A9LqA64izjwoaDGQCW8IhfbJhliNf_OjDK5t4V-GYIVGNkRo4JWpCD16axNp7c8LyLV8G_iEs0fIATsJZB_gUyB6gv8whrpxOr/s320/regz.gif" alt="Zach's cat trying to get in from the screen porch, with the humorous caption, 'Can I Has Regz?'" width="400"/></a>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com1tag:blogger.com,1999:blog-525778292565554519.post-28905340717979500872016-12-09T13:27:00.001-05:002016-12-09T16:27:46.678-05:00Big Data researchers call for IRB review, based on shaky premises<p>Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.</p><br />
<p>[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” <em>Big Data & Society</em> 3, no. 1 (January–June 2016): 1–14, <a href="http://dx.doi.org/10.1177/2053951716650211">doi:10.1177/2053951716650211</a>.]</p><br />
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<h2>Assumptions about assumptions</h2><br />
<p>Metcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.</p><br />
<p>They write,</p><br />
<blockquote><p>US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)</p></blockquote><br />
<p>And</p><br />
<blockquote><p>The Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)</p></blockquote><br />
<p>And</p><br />
<blockquote><p>The criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on <em>what kind</em> of data is obtained and <em>how</em> it is obtained, not <em>what is done</em> with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM. While this may have once been a reasonable principle, current data science methods make this a faulty assumption. (8. Italics in original.)</p></blockquote><br />
<p>At no point do they cite any evidence that regulators excluded publicly available material from review out of the belief that it bore no risks.</p><br />
<p>Here’s what the regulators had to say when they released the 1981 regulations, which introduced the present definition of research:</p><br />
<blockquote><p>Several commentators felt that the definition is too broad and should be restricted to biomedical research. These commentators felt that the definition should not encompass subjects not at risk, social science research, or historical research; and some preferred voluntary application of the regulations to behavioral research. In contrast, a few commentators suggested that the definition should encompass research which is so specific as not to yield generalizable results. One commentator argued that the definition violated the First Amendment or at least academic freedom in the area of biographic research …</p><br />
<p>HHS has reinserted the term “private” to modify “information.” This modification is intended to make it clear that the regulations are only applicable to research which involves intervention or interaction with an individual, or identifiable private information. Examples of what the Department means by “private information” are: (1) Information about behavior that occurs in a context in which an individual can resonably expect that no observation or recording is taking place, and (2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. In order to constitute research involving human subjects, private information must be individually identifiable. It is expected that this definition exempts from the regulations nearly all library-based political, literary and historical research, as well as purely observational research in most public contexts, such as behavior on the streets or in crowds.</p></blockquote><br />
<p>In addition to the definition of human subjects research (which does not include studies of public information), the 1981 regulations introduced the exemption for “Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.”</p><br />
<p>HHS explained this decision as well:</p><br />
<blockquote><p>HHS is concerned about preservation of the confidentiality of data pertaining to human subjects but feels that other federal, state, and local laws or regulations are sufficient to protect the privacy of individuals and the confidentiality of records in cases where the research uses only existing information. It remains the responsibility of the investigator as well as the institution to ensure that such laws and regulations are observed and that the rights of subjects are protected. </p><br />
<p>[Department of Health and Human Services, “<a href="https://web.archive.org/web/20120925170358/http://www.hhs.gov/ohrp/archive/documents/19810126.pdf">Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects</a>,” <em>Federal Register</em> 46 (26 January 1981): 8336–8392]</p></blockquote><br />
<p>In neither case did HHS assume that data research would be harmless. In defining research, regulators responded to researchers' concern about freedom (a word that does not appear in the Metcalf and Crawford article). They explicitly responded to critics who argued that researchers should be able to do library research without getting anyone’s permission. In crafting the exemption, regulators recognized a privacy risk but did not believe that IRBs were the correct solution to that problem.<br />
<br />
<h2>IRBs are not the solution</h2></p><br />
<p>And IRBs are not the solution. Metcalf and Crawford imagine wonderful things about IRBs.</p><br />
<blockquote><p>Importantly, the ethics regulations targeted by critics, and the codes that informed those regulations, have played no small part in maintaining that trust over time. Insofar as physician–researchers contributed to the formation of those codes and regulations, and the broader research community assented to them (even if begrudgingly), research ethics regulations have built the bedrock of trust that has ultimately enabled research to occur at all. Therefore, even if the research/practice distinction as codified in the Common Rule proves too unwieldy for the methods of data science, we still need regulatory options that build trust between data practitioners and data subjects. (5)</p></blockquote><br />
<p>The citation here is to Polonetsky, Tene and Jerome, “<a href="http://ctlj.colorado.edu/?page_id=238">Beyond the common rule: Ethical structures for data research in non-academic settings</a>,” <em>Colorado Technology Law Journal</em> 13 (2015). That article speculates about how new institutions might build trust, but it does not claim, much less show, that IRBs serve this function. </p><br />
<p>Most people haven’t heard of IRBs. IRB review has not calmed public controversy over studies like the Kennedy Krieger lead paint study or SUPPORT. And as <a href="http://www.institutionalreviewblog.com/2012/09/could-guidance-and-feedback-replace.html">Murray Dyck and Gary Allen</a> have noted, “Mandatory multiple reviews of multisite research indicate that IRBs do not trust the merit and integrity of other IRBs.” If IRBs don’t trust each other, why should the public?</p><br />
<p>“The Common Rule needs to reflect that even anonymous, public data sets can produce harms depending on how they are used,” write Metcalf and Crawford. “The best way to do this in academic settings remains the IRB.” They offer no reasoning behind this claim.</p><br />
<p>Indeed they continue,</p><br />
<blockquote><p>As for industry, there needs to be a more serious commitment to review and assessment of human data projects. Facebook, for example, responded to the public outcry about the emotional contagion experiment by setting up an internal review process for future experiments. Legal scholar Ryan Calo has argued that a body like the Federal Trade Commission could commission an interdisciplinary report on data ethics, and that those public principles could guide companies as they form small internal committees that review company practices. Polonensky et al. have similarly argued for a two-track ethics review model for use outside of the purview of the Common Rule that would blend internal and external perspectives. Dove et al. recently surveyed how research ethics committees have grappled with data-intensive research with ‘‘bottom-up’’ approaches when more traditional ‘‘top-down’’ approaches have fallen short. Others have also offered promising insights for integrating ethical reasoning into data science research and practice prior to the typical timing of formal ethical review.</p></blockquote><br />
<p>Any one of those approaches, especially the last two, sound better than the current IRB system, which empowers pseudo-experts to arbitrarily block research they do not understand. So why single out university-based data researchers for the misery of a broken system they have so far escaped?</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-61951976758329032082016-12-07T15:58:00.000-05:002016-12-07T15:58:09.606-05:00Will Cures Act Replace Common Rule Reform?<p>As of November 15, <em>POLITICO</em> thinks that Common Rule reform is dead:</p><br />
<blockquote><p>HHS’s controversial revision of the Common Rule, the regulations that protect participants in clinical research, still hasn’t been sent to OMB for review. That’s not likely to get finished under Obama’s watch. </p><br />
<p>(David Pittman, “<a href="http://politi.co/2fC1q0T.">Obama’s HHS, Congress at Potential Odds over Pending Rule</a>,” POLITICO, November 15, 2016)</p></blockquote><br />
<p>On the other hand, <a href="http://www.nytimes.com/2016/12/07/us/politics/21st-century-cures-act-senate.html">Congress just passed the 21st Cures Act</a>, which includes a provision for a <a href="http://www.sciencemag.org/news/2016/11/new-us-research-policy-board-would-aim-slash-regulatory-paperwork">Research Policy Board</a> designed, as <em>Science</em> puts it, to “examine excessive regulation of research.”</p><br />
<p>In his <a href="http://docs.house.gov/meetings/SY/SY15/20160929/105394/HHRG-114-SY15-Wstate-LutherJ-20160929.pdf">September 29 testimony before the Subcommittee on Research and Technology</a>, James Luther of Duke University suggested that the congressional effort could replace the executive one. He complained “that HHS is still trying to move forward with a final rule [for human subjects research] for which many of the proposals remain unchanged from the ANPRM despite overwhelmingly negative comments” about its provisions on biospecimens. And he suggested that a Research Policy Board might do a better job.</p><br />
<p>Perhaps such a board would attend to questions of concern to the social sciences and humanities, but I am not hopeful. Luther’s testimony cites the <a href="http://www.institutionalreviewblog.com/2016/05/nprm-comments-focus-on-biospecimens.html">May 2016 analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU)</a> and the <a href="http://www.institutionalreviewblog.com/2016/07/the-ethical-imperialism-of-nas.html">June report by the National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements</a>. Both of those documents mostly ignored the social sciences and humanities.</p><br />
<p>The sun never sets on the Ethical Empire.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-53521413909222713592016-10-31T12:16:00.001-04:002016-10-31T12:16:57.370-04:00Qualitative Sociologists Find Standard Randomness<p>Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.</p><br />
<p>[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” <em>American Sociologist</em>, October 6, 2016, 1–17, <a href="http://dx.doi.org/doi:10.1007/s12108-016-9331-z">doi:10.1007/s12108–016–9331-z</a>. Note: I read a version of this article in manuscript and am so credited in the article.]</p><br />
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<br />
<h2>Standardization and arbitrariness can coexist</h2><br />
<p>The authors begin with a puzzle: </p><br />
<blockquote><p>Researchers … have raised concerns about two apparently contradictory problems. On the one hand many studies have observed that different local IRBs arrive at inconsistent decisions regarding the same research proposal, causing significant difficulties for biomedical researchers working across multiple institutions… . On the other hand, researchers in the social sciences and humanities, especially qualitative interview researchers, are more likely to charge IRBs with extending homogeneous, biomedical standards to different kinds of research . . . Why does standardization appear to be such a dominant theme in qualitative researchers’ experiences with their IRBs?</p></blockquote><br />
<p>As the following page makes clear, this is not so difficult a conundrum. What researchers colloquially call the “IRB” is more properly understood as a human research protection program (HRPP) with two parts. First, the institutional review board itself, composed (in a university setting) mostly of faculty, and second, the IRB administrative staff that conducts the initial screening and sets up forms and procedures. The staff component imposes highly standardized rules, then feeds any procedures raising concerns to the IRB itself, which abandons standards. </p><br />
<p>It’s like going to the airport and making it through a list of security procedures—photo ID, boarding pass, shoes off, belt off, liquids in a clear bag, laptop out—only to board a plane whose destination will be chosen based on the pilots’ whim after they’ve taken off. </p><br />
<h2>Few qualitative sociologists like the IRB process as it now exists</h2><br />
<p>Babb et al. interviewed “26 sociologists at nine institutions of higher education in the Northeastern United States.” Though they included institutions whose sociology chairs offered “a range of reported IRB experiences—two more negative, three more positive, and three mixed,” only two of the 26 people they interviewed “believed that IRB review was both important and legitimate in its current form,” and one of those serves on an IRB. Of the remaining 24 respondents, six “felt that IRB regulation of sociological research was antithetical to professional norms and illegitimate” and 18 described “a conflicted sense of regret that a system designed to attend to an important issue was causing problems.”</p><br />
<h2>Rejection isn’t the problem</h2><br />
<p><a href="http://www.institutionalreviewblog.com/2012/05/aahrpp-claims-irbs-rarely-disapprove.html">IRB apologists occasionally point to a low rejection rate as a sign that the system works</a>. This article reminds us that IRBs don’t need to reject a proposal formally to hinder research.</p><br />
<blockquote><p>Michael, at State University remarked that “there’s a lot of work to do to get the IRB to decide they’re not all that interested in what you’re up to.” Completing an IRB protocol—an extended form describing a research project–can take a significant investment of time, even where the research is very low risk. However, the most common concerns about paperwork were related not to the burden of initial application, but rather to “serial reapplication”—that is to say, the submission of multiple versions of the same protocol before receiving approval. As one researcher put it, “they want a great deal of information on exactly what questions will be asked and procedures for maintaining confidentiality, and … they often then go back and ask for more information again” (George, Eastern University). Gabrielle, at State University, similarly recalled her experience:, “they’ll send back a thing ‘what about this, what about this, what about this’ and now, you know, they can’t possibly have a form that would imagine every possible situation… [I]t took a good 6 to 9 months of just trying to…come up with a protocol that would appease them.”</p></blockquote><br />
<p>and</p><br />
<blockquote><p>Several researchers reported that they had decided not to do specific projects in order to avoid the hassle of getting through IRB. One claimed that she had “sworn off of doing any human subjects research anymore… I’ve found the process so crazy-making that … I just don’t want to deal with it anymore” (Gabrielle, State University).</p></blockquote><br />
<h2>IRBs lack expertise</h2><br />
<ul><li>They know less than researchers:</li>
</ul><br />
<blockquote><p>Penelope, at Public University, recalled the months it took to process a student proposal to study a social movement in a conflicted region in Turkey—a situation about which IRB decision-makers had neither knowledge nor appropriate precedents. As she concluded: “it’s a group of people trying to think through the repercussions of something that they probably have less familiarity with than the researcher does.”</p></blockquote><br />
<ul><li>They don’t accept standard methods:</li>
</ul><br />
<blockquote><p>At Urban University, a graduate student studying an anti-administration student social movement at another university was told he needed permission from that university’s administration. Barbara, the student’s advisor, remarked that “if the people studying the labor movement had to get permission from the factory owners, then nobody would have ever studied the labor movement!” Another example was the universal requirement of de-identifying informants–even in journalistic-style research where informants agreed to be quoted and where the credibility of the research rested on the attribution of quotes to well-known public figures. Still another example was snowball sampling: two researchers from Eastern University reported that their IRB had prohibited such sampling and suggested instead recruitment techniques commonly used in biomedical research, such as posting flyers in public places.</p></blockquote><br />
<ul><li>They fetishize written consent forms:</li>
</ul><br />
<blockquote><p>Thirteen of our 26 researchers mentioned the requirement of signed informed consent forms as an issue they had encountered. For example, Clara from Rural College wanted to interview adult passers-by at a conference convention booth. Clara’s IRB required that she obtain signed consent forms; however, she found that the consent document posed insurmountable obstacles. As she put it “…[y]ou’re asking them for all this personal information…and you want them to sign a form that says that they’re giving permission for this interaction, and as soon as you pull out the form, they say, ‘no I don’t have time.’” George at Eastern University had seen the problems IRB informed consent requirements posed for graduate students engaging in participant observation: “they somehow expect that everything will come to a halt while the graduate students pull out a form and explain to people they’re talking with what it means and get their approval.” Consent forms were seen as particularly problematic when they were long, legalistic, and difficult to read, as several of our respondents complained.</p></blockquote><br />
<h2>Researchers sometimes evade</h2><br />
<p>In 2007, <a href="http://dx.doi.org/10.1080/10508420701309614">Mark Ashcraft and Jeremy Krause</a> interviewed 100 researchers, of whom 19 reported collecting data without IRB approval. An even higher percentage (6 of the 26, or 23 percent) of the respondents here “reported that they had either evaded IRB rules themselves or recommended that their students do so.”</p><br />
<blockquote><p>Clara from Rural College, for example, discovered that it was impossible to interview passers-by if she presented them with the lengthy informed consent form required by her IRB (see quote above). Upon finding that people were unwilling to talk to her as soon as she presented the form, she decided to dispense with it. As she put it, “I just decided that I could either do field research or I could work with the IRB, but I couldn’t do both.” George, who had mentored graduate students doing qualitative research that had encountered similar obstacles, felt that “graduate students really are faced … with a choice of … either conforming to these rules and … not being able to do participant observation the way it should be done, or ignoring the committee…” (George, Eastern University).</p></blockquote><br />
<h2>People matter</h2><br />
<p>As much as we might wish for a magic structural fix to IRB issues, for now, the best hope is to fill the IRB with good people and, more importantly, to hire the right staff. Babb et al. describe two institutions that had generated horror stories in the past but now seem to be getting better:</p><br />
<blockquote><p>At Urban University, professional IRB administration appeared to be working relatively well for qualitative researchers. Urban’s IRB was run by a dynamic administrator who was committed to meeting personally with all researchers before they submitted protocols and engaging in back-and-forth communication. Barbara described this administrator as an enormous improvement over her predecessor in the position: “prior to that it just felt a little bit more like a black box, you know the IRB has its own email address…now I know that when I send something to that address it’s [the administrator’s name]…before then, what happened at the other end [laughs] of that email address was much less clear.” Because she was open to personal communication, it was possible for researchers to engage with her directly, and explain their reasoning if they thought a mistake was being made. An Urban University scholar described one case (the factory study that ran into the problem of site permission, described above) in which such engagement led to the reversal of the administrator’s previous decision.</p></blockquote><br />
<p>and</p><br />
<blockquote><p>At Yankee College, the old IRB chair had recently been replaced by Sam, a qualitative sociologist who had assembled a new group of faculty IRB volunteers to improve and clarify rules and procedures, and who made an effort to communicate with researchers directly rather than bureaucratically. </p></blockquote><br />
<p>At its best, then, the IRB system works as a government of men, not of laws. Can we do better?</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-16552842114115965922016-10-25T12:05:00.001-04:002016-10-25T12:05:36.525-04:00Final Rule in 2016?<p><a href="https://twitter.com/theresadefino">Theresa Defino reports</a> that OHRP “hopes to get ‘something’ out by year end.” </p><br />
<p>If OHRP were to liberate oral history on the <a href="http://www.institutionalreviewblog.com/2006/12/introduction.html">10th anniversary of this blog</a>, that would be OK with me.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-48698695863583691812016-10-02T11:59:00.000-04:002016-10-02T11:59:25.813-04:00Brazil calls for "equitable representation from the Social Sciences and Humanities"<p>Brazil is revising its research ethics standards in ways that will help tailor them to research in the social sciences and the humanities. The standards provide for greater representation by scholars in those fields when policies and decisions are made, and they decenter some of the medical assumptions that had previously governed all research. But they do not go as far as the Canadian TCPS2 in recognizing the legitimacy of critical inquiry.</p><br />
<p>[Iara Coelho Zito Guerriero, “Approval of the Resolution Governing the Ethics of Research in Social Sciences, the Humanities, and Other Disciplines That Use Methodologies Characteristic of These Areas: Challenges and Achievements,” <em>Ciência & Saúde Coletiva</em> 21, no. 8 (August 2016): 2619–29, <a href="http://dx.doi.org/10.1590/1413-81232015218.17212016">doi:10.1590/1413–81232015218.17212016</a>.]<br />
<a name='more'></a> </p><br />
<p>In Brazil, a National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, or CONEP) oversees each local Research Ethics Committee (Comitê de Ética em Pesquisa, or CEP). As in other countries, medical researchers and health officials have dominated the crafting of policy, resulting in restrictions that make little sense for research in the social sciences and humanities (SSH). </p><br />
<p>Since 2013, public health researcher Iara Guerriero and other members of a Working Group in Social Sciences and Humanities have labored to improve this situation, and in April 2016 they won National Board of Health approval for their resolution. In her article, Guerriero publishes the resolution and notes four major advances:</p><br />
<ol><li>Equitable composition of CONEP and involvement of SSH members in reviewing the protocols for these areas.</li>
<li>Recognition that scientific merit must be assessed by competent areas.</li>
<li>Discrimination between the process of obtaining and registering consent.</li>
<li>Explanation of studies that do not require analysis by the REC/CONEP system, where the preliminary steps are not assessed.</li>
</ol><br />
<p>Since a major finding of <em><a href="https://jhupbooks.press.jhu.edu/content/ethical-imperialism">Ethical Imperialism</a></em> was that inappropriate regulations are the product of the exclusion of social scientists and humanities research from policy making, I am particularly encouraged by the first advance. Article 26 of the resolution states that</p><br />
<blockquote><p>The ethical analysis of the study projects to which this Resolution refers can only be done by Research Ethics Committees that have an equitable representation of members from the Social Sciences and Humanities area, with the reporters being selected from among those members qualified in this area of knowledge.</p></blockquote><br />
<p>Achievements 3 and 4 are also potentially quite significant. One of the enduring complaints of social scientists over the decades has been the poor fit between experimental models, which expect protocols to be designed in advance of any research, and the actual practices of qualitative researchers, whose projects evolve less predictably. <a href="http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter10-chapitre10/">Canada’s TCPS2</a> states that “REBs should be aware that it is quite common for specific questions (as well as shifts in data sources or discovery of data sources) to emerge only during the research project,” and it sounds as though Brazil is moving in that direction as well.</p><br />
<p>The Brazilian resolution does not mention historical research, journalism, or any form of critical inquiry, and I am troubled by Article 3, section VIII, which presents the principle of “Researcher assurance that the information obtained as a result of the study will not be used to harm participants.” As I have <a href="http://www.institutionalreviewblog.com/search/label/critical%20inquiry">repeatedly noted on this blog</a>, journalists, historians, political scientists, sociologists, and even anthropologists have acknowledged that some research is legitimately critical of the people it concerns, and there is nothing wrong in using someone’s freely given words against them. </p><br />
<p>“This is a time of celebration and much hard work,” writes Guerriero, and it certainly sounds as though Brazil’s social science and humanities researchers have taken a step forward. But I hope that as they challenge the imposition of medical norms on nonmedical fields, they will follow <a href="http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#toc03-1a">Canada’s lead in recognizing the legitimacy of critical inquiry</a>.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-58989769073827527082016-10-01T12:37:00.000-04:002016-10-01T12:37:07.282-04:00"One more impediment to getting a worthwhile project done"<p>A final horror story posted in response to Patricia Aufderheide’s essay, “<a href="http://www.chronicle.com/article/Does-This-Have-to-Go/237476">Does This Have to Go Through the IRB?</a>."</p><br />
<p><a href="http://brianabelragen.net/">Brian Abel Ragen</a> writes,</p><br />
<blockquote><p>Eventually you will probably find a reasonable person to stop the nonsense. That was my experience when one of my graduate students was told that his plan to interview a writer for the New York Review of Books meant he was using “human subjects” and therefore needed to submit his thesis proposal to the IRB after filling out all the appropriate forms and applications. A student asking a professional literary critic why he had championed the reputation of a certain novelist was, quite rightly, seen as an interaction WITH a fellow human being, not research ON a human subject. But that should have been obvious from the beginning. What the whole process did for me as an English professor and my student in the humanities was to create just one more impediment to getting a worthwhile project done—this new obstacle laced with fear of getting in trouble with the Federal government if we made a mistake. It also protected a writer from hearing from someone who admired his work and wanted to explore it with him for a few weeks. So I would say that the limits of the IRB’s powers need to be more clearly drawn, so as to remove one more hazard from the already obstacle-strewn path to completing a degree or a research project. I won’t say that i can’t imagine projects in literary studies that don’t involve using people as actual “human subjects,” but I think the default assumption should be that any project that involves neither deception nor asking the interlocutor to do anything but talk about something is beyond the scope of an IRB.</p></blockquote><br />
<p>An IRB need not block a project to discourage curiosity.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-46247467586130173402016-09-30T18:03:00.001-04:002016-09-30T18:03:25.070-04:00IRB consent form spooked respondents<p>Commenting on Patricia Aufderheide’s essay, “<a href="http://www.chronicle.com/article/Does-This-Have-to-Go/237476">Does This Have to Go Through the IRB?</a>,” a writer with the screen name “reinking” relates:</p><br />
<blockquote><p>I was investigating a routine instructional intervention in a school district serving a large hispanic population. IRB required, not just that the consent form be translated into Spanish (not unreasonable if a consent form was necessary), but also that I develop several versions in different dialects. Nonetheless, when sent to parents, remarkably few were returned, and I eventually determined why. The standard template for IRB consent (modeled on far riskier medical research) indicated that any questions or concerns should be directed to me as “principal investigator.” “Investigator” was apparently a term (in English or Spanish) that set off alarm bells among parents in this hispanic community.</p></blockquote><br />
<p>So much for IRB sensitivity to local conditions.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-18130236617555879532016-09-19T18:53:00.000-04:002016-09-19T18:53:30.526-04:00More failures of "local precedents"<p>Laura Stark’s 2012 book, <em><a href="http://press.uchicago.edu/ucp/books/book/chicago/B/bo12182576.html">Behind Closed Doors: IRBs and the Making of Ethical Research</a></em>, devotes a chapter to what Stark calls “local precedents,” her term for “the past decisions that guide board members’ evaluations of subsequent research.” “By drawing on local precedent,” Stark claims, “board members can read new protocols as permutations of studies that they have previously debated and settled based on members’ warrants. The result is that IRBs tend to make decisions that are locally consistent over time.” (47)</p><br />
<p>But I keep getting stories about IRBs that are locally inconsistent.<br />
<a name='more'></a><br />
Stark made her generalization after observing a handful of cases in which IRBs claimed to be either basing decisions on ones they had previously made, or making new decisions that would guide future rulings. But as far as I can tell, she did not systematically audit IRB files to test the degree to which IRB decisions are in fact locally consistent.</p><br />
<p>I have long had my doubts about this claim of consistency, since so many stories from frustrated researchers concern identical studies presented to the same IRB with differing results. “The process that was <a href="http://www.institutionalreviewblog.com/2014/12/horror-story-buffet.html">approved in the first application was denied in the second</a> because it was deemed coercive,” one complaint notes. “In every case in which we submitted the approved IRB application from the previous year, <a href="http://www.institutionalreviewblog.com/2016/05/texas-irb-imposed-review-for-surveys-of.html">the IRB required additional changes</a>,” another laments. A candid IRB chair admits that “Investigators may get <a href="http://www.institutionalreviewblog.com/2015/09/schrag-reviews-klitzman-ethics-police.html">quite different and inconsistent advice</a> from the committee depending on what it feels like that day.”</p><br />
<p>Two comments posted in response to Patricia Aufderheide’s essay, “<a href="http://www.institutionalreviewblog.com/2016/09/a-satisfied-customer-at-american.html">Does This Have to Go Through the IRB?</a>,” cast further doubt on claims of local consistency. Here they are, with the screen names of the authors:</p><br />
<p>kgs_ssu </p><br />
<blockquote><p>At a university I don’t work at, I had a series of go-rounds regarding a caveat I placed in a proposal that boiled down to explaining that the participant pool I was working with is very small and there’s a chance some of the participants will talk to one another about this research. I had used identical language in two previous proposals at the same university. To appease the reviewer (who also strayed from reviewing to critique other areas of the proposal) I eventually removed the statement, even though I felt it was ethically appropriate to point this out and an unavoidable outcome of the type of research I am doing. The IRB personnel I worked with in that office helped as a go-between, but what a waste of time for her and for me, and I felt a tad compromised in the process.</p></blockquote><br />
<p>ergative:</p><br />
<blockquote><p>At one of my previous institutions, the IRB disliked the size of the font on the recruitment flyer I wanted to put up around campus, saying that the size in which I indicated the amount of compensation was too big relative to the size of the words saying “research study,” and therefore that constituted undue influence to participate. Silly, but I guess I can run with it, except that I used the exact poster template that my lab had been using for years under a different protocol. Depending on who or when the protocol was reviewed, absurd ticky-tack font-size objections would require corrections and resubmissions of the protocols, which resulted in an additional three or four weeks of waiting for approval.</p></blockquote><br />
<p>Such stories do not reveal the extent of IRB inconsistency, but neither do Stark’s observations. Without further investigation, I don’t think she can support the claim that “IRBs tend to make decisions that are locally consistent over time.”</p><br />
<p>Also, note how in the first story, the IRB interference had the effect of denying useful information to prospective participants. </p><br />
Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0tag:blogger.com,1999:blog-525778292565554519.post-15964088005855295632016-09-06T11:27:00.001-04:002016-09-06T11:27:38.359-04:00A satisfied customer at American University<p>Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.</p><br />
<p>[Patricia Aufderheide, “<a href="http://www.chronicle.com/article/Does-This-Have-to-Go/237476">Does This Have to Go Through the IRB?</a>,” <em>Chronicle of Higher Education</em>, August 17, 2016.]<br />
<a name='more'></a> </p><br />
<p>Aufderheide writes that the AU IRB, “which primarily deals with social-science and humanities research, has been more helpful to me than I ever expected it to be.” IRB staff review, she writes, helped her and a colleague think through reasons why the people they interviewed might hesitate to be interviewed, and the protocols they worked out gave them “a clear signal at the start of our work together that we were conscientious and considerate professionals.”</p><br />
<p>Aufderheide credits the people involved. The IRB includes faculty in marketing, public opinion research, government, psychology, international relations, as well as a librarian. This is a far larger range of disciplines than most social scientists can hope to face, and AU is to be applauded for securing such intellectual diversity. Moreover, Aufderheide credits the unfailing patience of Matt Zembrzuski, the research compliance manager, who directs IRB operations.</p><br />
<p>But Aufderheide’s raises some troubling issues as well, which suggest that not everything is as rosy at AU as she suggests, and that other universities may have trouble replicating the experience.</p><br />
<h2>Why is Aufderheide destroying records?</h2><br />
<p>The only research project that Aufderheide describes in any detail is an ongoing collaboration with Peter Jaszi to interview “creative colleagues on how they did their work, given their understanding of copyright.” As she describes the protocol,</p><br />
<blockquote><p>Our research team gave interviewees an informed-consent form that said in simple words what we were trying to find out and why, why we valued their time, what we thought the risks were, and how we would deal with those risks. We promised not to use their names in any published material, unless they wanted to be named (a surprising number did). We kept all the information in a passworded project-management site (Basecamp), and we deleted all the data after we completed our research.</p></blockquote><br />
<p>If respondents are willing to have their names used, why destroy <em>all</em> data? Why not give the participants the chance to have their interviews archived so that future generations can learn how copyright affected creative practice in the early 21st century? There’s gold in the interview outtakes. As Pat Bowne comments on the <em>Chronicle</em> site, “the phrase ‘delete the data afterwards’ sounds about as bad as ‘kill all the witnesses.’”</p><br />
<h2>Does the AU IRB understand minimal risk?</h2><br />
<p>Again, the essay is mostly vague about the projects reviewed by the IRB and the changes it demands, but it quotes Molly O’Rourke, a public-opinion researcher, in more detail:</p><br />
<blockquote><p>“Example, asking about the number of children someone has or marital status seems very standard — but not for a respondent who lost a child or is in the process of a painful divorce or separation,” said O’Rourke, the public-opinion researcher. “Appreciating that and writing research instruments that reflect that is hard but important.” She added: “I will never forget moderating a focus group about terrorism/national security in 2002, and I had someone in the session whose brother was killed in the World Trade Center on 9/11. … We somehow missed it in the prescreening. Having been invited to a focus group about ‘policy priorities for our country,’ she (rightfully) felt misled.”</p></blockquote><br />
<p>The first statement confuses the questions of whether a question is standard and whether the response to that question is standard. Questions about marital status are in fact quite standard. Every year the IRS asks about whether I’ve lost any family members, and for that reason my marital status is listed on my pay stub, issued twice a month. I rather doubt that someone who is grieving a dead child needs a questionnaire to be reminded of that fact. And while I feel sympathy for the woman whose brother was killed, I find it hard to believe that anyone in 2002 could imagine that a discussion of national policy priorities would not address responses to 9/11. What else did people talk about in 2002? O’Rourke appears to be trying to shield research participants from risks comparable to “those ordinarily encountered in daily life,” and that is not the IRB’s job.</p><br />
<h2>Does the whole system depend on a benevolent despot?</h2><br />
<p>Aufderheide’s emphasis on Zembrzuski rings true to me; I’ve seen at other universities (including my own) the importance of a patient, reasonable compliance manager. But academic freedom should not depend on one person’s temperament, which is why structural reforms, such as a guaranteed appeals process, are so important.</p><br />
<h2>Are other AU researchers as pleased as Aufderheide?</h2><br />
<p>Aufderheide’s essay quotes only members of the IRB, not any researchers who have faced the IRB without serving on it. This is like asking the foxes how they feel about guarding the henhouse. To be sure, I have not found in my notes any IRB horror stories emanating from AU. But I do recall one conference, some years back, when a VP of another major research university spoke confidently about how well the IRB worked at her institution, only to be immediately contradicted by a graduate student from the same university, who told the VP how deluded she was. I would be interested to hear from other AU researchers if their experience matches Aufderheide’s.</p>Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.com0